EP1631193A1 - Systeme de prelevement sanguin - Google Patents

Systeme de prelevement sanguin

Info

Publication number
EP1631193A1
EP1631193A1 EP04729840A EP04729840A EP1631193A1 EP 1631193 A1 EP1631193 A1 EP 1631193A1 EP 04729840 A EP04729840 A EP 04729840A EP 04729840 A EP04729840 A EP 04729840A EP 1631193 A1 EP1631193 A1 EP 1631193A1
Authority
EP
European Patent Office
Prior art keywords
lancet
protection element
blood
lancet tip
blood collection
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04729840A
Other languages
German (de)
English (en)
Inventor
Paul Jansen
Juergen Rasch-Menges
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Original Assignee
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG, Roche Diagnostics GmbH filed Critical F Hoffmann La Roche AG
Publication of EP1631193A1 publication Critical patent/EP1631193A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150312—Sterilisation of piercing elements, piercing devices or sampling devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15149—Arrangement of piercing elements relative to each other
    • A61B5/15153—Multiple piercing elements stocked in a single compartment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15174—Piercing elements stocked in the form of a stack or pile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism

Definitions

  • the invention relates to a blood collection system for drawing blood for analysis or diagnosis purposes.
  • test methods are used which work with test elements.
  • the test elements contain reagents.
  • the test element is brought into contact with the sample.
  • the reaction of the sample and the reagent leads to a change in the test element which is characteristic of the analysis and which is evaluated with the aid of a suitable evaluation device.
  • the evaluation device is . generally suitable for the evaluation of a particular type of test elements of a particular "manufacturer.
  • the test element and the evaluation unit forming mutually matched components and are collectively referred to as an analysis system.
  • test elements Numerous different types of test elements are known, which differ in the measuring principle and the reagents used and in their structure.
  • colorimetric analysis systems are particularly widespread. With them the reaction of the sample with those contained in the test element leads Color change reagents that can be measured visually or using a photometric measuring device.
  • electrochemical analysis systems have become very important, in which the reaction of the sample with the reagents of the test element leads to an electrically measurable change (an electrical voltage or an electrical current), which is measured with appropriate measuring electronics.
  • test strips strip-shaped test elements
  • the test fields usually consist of one or more test layers containing reagents.
  • Such test strips are widely used in particular for blood and urine tests.
  • test field like a photographic slide
  • the test field of this type of test element usually consists of one or more test layers which are held by the frame and contain reagents suitable for colorimetric tests. After application of the sample to the test field and completion of the test reaction, the color formation can be observed or measured photometrically.
  • lancets In order to draw a small amount of blood from a part of the body (usually the finger or the earlobe) for such analytical-diagnostic purposes, lancets are used which are inserted into the corresponding part of the body. As far as the lancets are inserted manually into the skin to create a wound specially trained personnel required. However, the puncture is associated with considerable pain.
  • Blood collection systems have been used for a long time, which consist of a lancing device and associated lancets specially adapted for the device in question.
  • a lancet drive is contained in a housing of the lancing device, through which a lancet mechanically pierces the skin . becomes.
  • this is also not painless, and there are various developments to make blood collection as painless as possible.
  • a blood collection system is not only expected to meet the requirement for minimal pain sensation, but at the same time it should be simple to operate, have a compact, slim design and enable a simple, inexpensive construction. Based on these practical requirements, blood analysis devices have been and are being developed that meet these partially contradicting requirements as far as possible.
  • horn monitoring that is, where medical laypersons carry out simple blood analyzes themselves, and there in particular for the regular blood collection by diabetics to be carried out several times a day for the control of blood glucose.
  • concentration, lancets and matching devices, so-called “lancing aids” are offered that enable blood to be obtained as painlessly and reproducibly as possible.
  • Such small amounts of blood do not require venipuncture but can be obtained using a sterile, sharp lancet which is pushed through the skin, e.g. into the fingertip or the earlobe of the person to be examined. This method is particularly suitable if the analysis of the blood sample can be carried out immediately after blood collection.
  • the lancets used to remove body fluid from a body part by creating a small puncture wound usually have a metal lancet needle, the tip of which can be ground. These lancets must be kept sterile until they are used and should preferably be disposed of after use so that they cannot cause injury. Blood sampling systems have therefore been proposed in which the lancets are in a lancet storage container in which a plurality of lancets for removal from the lancet storage container are kept in stock at a removal position.
  • a possible embodiment of such a lancet storage container is a drum magazine from which the lancets can be removed individually, the lancets being arranged in chambers in the drum magazine, each of which is individually closed.
  • the used lancets are either disposed of outside the device or the analysis device or can also be returned to the lancet storage container for safe disposal after use.
  • the lancet dispenser comprises a housing with a lancet storage container arranged therein, a lancet guide, and a lancet drive.
  • Such blood analysis devices for example glucose meters, comprise in a device that is as compact as possible both a blood withdrawal system with lancets, a magazine for the lancets, an analysis device or an analysis system and the necessary test elements, likewise preferably in a magazine.
  • all the magazine materials, ie the lancets and the test elements are preferably disposed of after their use in the device, for example after use in the magazine returned and kept there until the entire magazine is replaced.
  • Disposables are used, which are an integrated combination of a lancet and a test element.
  • a lancet is provided or provided for a test element, which is integrated in the test element.
  • a fresh lancet is used each time the blood is drawn.
  • the result is a lancet magazine that takes up more volume in the blood analysis device than the magazine for the test elements.
  • Another problem with highly integrated blood analysis devices is that the time between starting a measurement process and performing an injection into the skin can be relatively long. From the point in time at which a measuring process is started, a time of up to 10 seconds can pass before the puncturing movement from the lancet into the skin is carried out. During this time, the body part to be stung, for example the finger, must be pressed against the outlet opening of the blood analysis device and the puncturing movement must be waited for.
  • the invention aims to solve the problems associated with the prior art blood collection systems that are associated with the multiple use of lancets. According to the invention, this object is achieved by a blood withdrawal system or a method for withdrawing blood with the features of the attached independent patent claims. Preferred refinements and developments of the invention result from the dependent patent claims and the following description with associated drawings.
  • a blood withdrawal system for withdrawing blood for analysis or diagnostic purposes thus comprises a housing with an outlet opening for the lancet tip of the lancet needle of a lancet, which can be moved in the housing along a predetermined insertion path, a lancet guide by means of which the lancet is guided on the predetermined one
  • the lancing path can be guided, a lancet drive, by means of which the lancet can be moved and moved along the predetermined insertion path in the insertion direction until its tip emerges from the outlet opening in a lancing position, and a lancet storage container which is arranged in the housing and in which a plurality of lancets for removal from the lancet storage container is kept in stock at a removal position, and has the special feature that it comprises a lancet tip protection element into which the lancet tip can be inserted before or after an insertion movement, the protection z element mechanically and hygienically protects an inserted lancet tip, and that the lancet tip protection element is arranged
  • a method for taking blood with a blood collection system for analysis or diagnosis purposes wherein the blood collection system comprises a housing with an outlet opening for the lancet tip of the lancet needle of a lancet, which is moved in the housing along a predetermined insertion path, comprises a lancet guide, by means of which the lancet is guided on the predetermined insertion path, comprises a lancet drive, by means of the lancet of which is moved and moved along the predetermined insertion path in the insertion direction until its tip emerges from the outlet opening in a lancing position, and comprises a lancet storage container which is arranged in the housing and in which a plurality of lancets for removal from the lancet If the storage container is kept in stock at a removal position, the special feature is that the lancet tip is inserted into a lancet tip protection element before or after a puncturing movement, the protection element mechanically and hygienically when a lancet tip is inserted therein enisch protects, and
  • a further standby position (the parking position) is provided, in which they are inserted into and protected by a lancet tip protection element become.
  • the first-time use of a lancet for blood collection can either be done in the usual way by removing it the lancet from the lancet storage container and directly fed to the outlet opening.
  • the lancet is used repeatedly from the parking position into which it is brought after the first use and the further uses before it is finally disposed of.
  • After the last use of a lancet for taking blood it can either be disposed of directly, for example in the lancet storage container or outside the device, but it can also be returned to the parking position before disposal in order to clean it and prevent contamination to avoid other elements, for example the lancet storage container.
  • the lancet can be largely cleaned, e.g. sterilized, and at the same time is protected against environmental influences, e.g. Shocks, protected.
  • the lancet is temporarily arranged in the park position, it can be kept ready for use there. If the arrangement and / or the travel path of the lancet is optimized in such a way that it can be fed from the parking position into the puncture position at the outlet opening in the blood analysis system faster than from the removal position in the lancet front container, the time that elapses before the piercing movement is carried out can be reduced as desired.
  • the lancet tip protection element and the parking position are arranged in the immediate vicinity of the outlet opening.
  • a mechanically inexpensive and thus preferred embodiment consists in that the lancet tip protection element is stationary, i.e. is arranged at a fixed place in the housing of the blood collection system or the blood analysis device. In other embodiments, however, it can also be provided that the lancet tip protection element can be moved onto the lancet tip by means of a drive.
  • the lancet tip protection element comprise an elastic material into which the lancet tip can be inserted.
  • This can be a plastic body, for example, which consists of an elastic material in the area of the lancet tip. At least the tip of the lancet needle is completely surrounded on all sides by this elastic material, ie embedded in it, and thus closed off from the surroundings.
  • the elastic material is characterized, for example, by the fact that it is soft, deformable and can be pierced by the tip of the lancet needle without damaging the lancet tip. Another important property of the elastic material is that it closes again when the lancet needle is withdrawn from the lancet tip protection element, so that the lancet needle is closed after one Lancing process or another lancet needle can be reinserted into the elastic material.
  • the elastic material provides mechanical protection for the lancet tip and thus prevents one
  • Suitable elastic materials are described in documents WO 01/66010 A1 and US 2001/0041904 A1. To this extent, these documents are referred to.
  • the lancet tip can remain protected before its first use or between uses and is kept sterile.
  • the soft plastic should be so soft that the lancet tip or lancet is not damaged when immersed and does not become excessively blunt.
  • the material should be so tough that it encloses the lancet well after multiple use, ie seals it, and does not crumble.
  • the lancet tip protection element comprises a sterilizing, microbicidal, inactivating, disinfecting, bactericidal or fungicidal material for cleaning or protecting the lancet tip. It is preferred if the elastic material described above is formed in this way 10. In the park position, a lancet is then both protected and cleaned and can therefore be used several times.
  • Suitable sterilizing materials are disclosed in document US 2001/0041904 A1, which is referred to in this respect.
  • Suitable materials are, for example, oxidants, phenols, epoxides, peroxides, polymers of formaldehyde and other mono-, di- and polyaldehydes (e.g. glutaraldehyde), systems containing hydrogen peroxides, complexes containing iodine and metal salts of
  • SAM polymers from Degussa for example Limago T100 or Amina T100, which have been shown to be admixed with a plastic, have proven to be particularly advantageous within the scope of the invention.
  • a blood withdrawal system according to the invention is preferably designed such that a lancet can be used multiple times for withdrawing blood and can be moved between the piercing movements into the lancet tip protection element.
  • a blood collection system or a corresponding blood analysis device can be designed such that the number of lancets provided is smaller than the number of associated test elements and not as in
  • Operating elements are advantageously provided, by means of which the user can specify whether a new lancet from the lancet storage container or a lancet already used for taking blood from the parking position in the lancet tip protection element is used for the subsequent blood withdrawal.
  • the user can decide at which point in time he wishes a new lancet if the lancet tip becomes less sharp and the resulting greater pricking pain occurs.
  • This can also be done, for example, in such a way that the user presets the number of blood withdrawals that are carried out with a lancet and the lancet is disposed of after this preset number of uses has been reached.
  • the invention proves to be particularly advantageous as a highly integrated analysis system, the system additionally containing test elements in addition to a lancet magazine. If both lancet and test elements are provided in the system, this results in a complex movement sequence of the lancet for exiting the housing - as described - since the lancet magazine cannot be positioned directly above the housing opening. A complex movement sequence in the X and Y directions is consequently required to carry out a lancing process, it being possible to simplify this movement sequence by the described parking position.
  • the blood collection system comprises a test element magazine which is integrated in the blood collection system, preferably arranged in the housing is.
  • the test element magazine is preferably exchangeable.
  • FIG. 2 shows step 1 of a sample collection according to FIG. 1,
  • FIG. 3 shows step 2 of a sample collection according to FIG. 1
  • FIG. 4 shows step 3 of a sample collection according to FIG. 1
  • FIG. 5 shows step 4 of a sample collection according to FIG. 1,
  • FIG. 6 shows step 5 of a sample collection according to FIG. 1,
  • FIG. 8 shows the structure of a glucose meter according to the invention
  • FIG. 9 shows a detail of FIG. 8,
  • FIG. 10 shows a further detail of FIG. 8, FIG. 11 shows a modification of FIG. 10,
  • FIG. 12 shows step 1 of a sample collection according to FIG. 8
  • FIG. 13 shows step 2 of a sample collection according to FIG. 8
  • 14 shows step 3 of a sample collection according to FIG. 8,
  • FIG. 15 shows step 4 of obtaining a sample according to FIG. 8
  • FIG. 16 shows step 5 of obtaining a sample according to FIG. 8,
  • FIG. 17 shows a modified step 1 of a sample collection according to FIG. 8,
  • FIG. 18 shows a modified step 2 of obtaining a sample according to FIG. 8,
  • FIG. 19 shows a modified step 5 of a sample collection according to FIG. 8,
  • FIG. 21 shows a detail of FIG. 20
  • FIG. 22 shows a further detail of FIGS. 20 and
  • FIG. 23 shows a further modification to FIG. 10.
  • FIG. 1 schematically illustrates the blood withdrawal system 1 of a blood analysis device 2 according to the prior art in the form of an integrated glucose meter in which the consumables required for the blood analysis are stored and the processes required for the blood analysis are integrated.
  • the test elements with which the blood drawn is analyzed are not shown for the sake of clarity.
  • the blood collection system 1 comprises a housing 3 with an outlet opening 4, from which a blood sample can be taken by means of a lancet 5.
  • the lancets 5 are located in a lancet storage container 6, which in the exemplary embodiment shown is a rotatable drum magazine.
  • the multiple lancets 5 are in the lancet ten storage container 6 and can be present, for example, loose or clamped by holding elements.
  • the lancet storage container 6 can be rotated about an axis of rotation 7 in order to bring a lancet 5 contained in the lancet storage container 6 and to be removed into a removal position.
  • a lancet drive 8 for example in the form of a lifting and swiveling unit with an adapted gripper 9
  • a lancet 5 can be removed from the lancet storage container 6 and transported to the location of the sample collection, the lancing position at the outlet opening 4 and after the blood withdrawal for disposal be transported back into the lancet storage container 6.
  • the lancet drive 8 can be pivoted about an axis of rotation 10 and can be moved along a linear axis 11 which is oriented in the piercing direction.
  • the lancet storage container 6 first rotates such that a lancet 5 to be removed, preferably the one from the next available position, is brought into the removal position in which it can be gripped by the gripper 9 of the lancet drive 8.
  • the lancet drive 8 first moves upward from a starting position (not shown) into a rotational position, then rotates the gripper 9 about the axis of rotation 10 into the receiving position, ie below the position of the lancet 5 to be removed from the lancet storage container 6, and then the lancet 5 is attached to the gripper 9 by a further movement upwards.
  • the lancet 5 is then pulled out of the lancet storage container 6 by the downward movement shown in FIG. 4 and has arrived in a position in which it can be rotated about the axis of rotation 10.
  • the lancet 5 is then positioned under the outlet opening 4 for sample collection by means of a rotary movement and the lancet 5 is moved upwards to or into the outlet opening 4 via a travel movement, where it is then in the lancing position.
  • a body part e.g. stored a fingertip 12.
  • the lancet 5 with the lancet tip located on the lancet needle can pierce the fingertip 12 or the skin surface of another part of the body placed on the outlet opening 4 and thereby obtain a small blood sample.
  • the lancet is removed
  • the lancet drive 8 first performs a downward movement to the rotational position.
  • the lancet drive 8 then turns the gripper 9 with the lancet 5 to be disposed of, the lancet storage container 6, to the now empty magazine position, and the lancet 5 used is moved into the lancet storage container by a subsequent movement upwards
  • the lancet drive 8 moves downward again, swivels back as shown in FIG. 7 and then moves downward into the starting position, not shown, from which the next blood withdrawal takes place.
  • the above-mentioned steps are repeated for a new blood withdrawal, a new lancet 5 being removed from the lancet storage container 6 in each case and all movements or routes will be repeated.
  • the prior art sequence described in FIGS. 2 to 7 has several disadvantages.
  • the travel paths and thus the travel times for the lancet drive 8 are long, so that the user has to wait a long time from triggering the blood withdrawal from the starting position of the lancet drive 8 until a lancet 5 is provided from the lancet storage container 6 and the piercing movement at the outlet opening 4 is carried out.
  • the lancet storage container 6 requires a relatively large amount of space, since a new lancet 5 is provided for each blood sample.
  • a blood collection system 1 according to the invention according to FIG. 8 The structure corresponds to that of the blood collection system according to the prior art according to FIG. 1, with the difference that it comprises a lancet tip protection element 13 into which the lancet tip can be inserted before or after an insertion movement, the protection element 13 being one therein protects the inserted lancet tip mechanically and hygienically.
  • the protective element 13 is arranged in a parking position of the lancets 5 on the lancet tip, ie the lancet tip is inserted into the protective element 13 in the parking position.
  • the parking position does not correspond to that Removal position, in which the lancet 5 is removed from the lancet storage container 6, and also not the lancing position at the outlet opening 4, in which blood is withdrawn.
  • the parking position for the lancet tip i.e. the position of the protective element 13 is preferably in the immediate vicinity of the outlet opening 4, preferably inside the housing 3.
  • Another advantageous embodiment can consist in the fact that the lancet tip protection element 13 is arranged in the lancet storage container 6, i.e. is integrated into the magazine.
  • the elastic material 15 wears out during use, for example the plastic is perforated or it becomes dirty (blood residues, skin flakes, environmental influences). For this reason, it is advantageous if the lancet tip protection element 13 or the elastic material 15 is not a solid, i.e. fixed or permanent part of the device, but is interchangeable.
  • the protective element 13 or the elastic material 15 it is possible to design the protective element 13 or the elastic material 15 as a disposable, that is to say as a consumable that the user must replace at intervals to be defined, e.g. as a separate article or as an addition to every pack of lancets 5. It is also possible to integrate the lancet tip protection element 13 into the lancet storage container 6. It is exchanged with each magazine change and does not burden the user with additional service actions to be monitored.
  • FIG. 9 shows a protective element 13, which is on the inside of the Housing 3 is arranged. It comprises a solid molded body 14 which is filled with an elastic material into which the lancet tip can be inserted. It is filled with a soft plastic, which is mixed with a sterilizing, germicidal agent.
  • the elastic material 15 protects the tip of the lancet 5 inserted therein from environmental influences, for example contamination, vibrations and associated damage, cleans it by wiping off the dirt when the lancet 5 is immersed in the elastic material 15 and disinfects it by the microbicidal admixture.
  • Gripping section 16 can be held protected from falling out by a holding device, not shown.
  • a holding device can function actively, i.e. have an active gripping element, or passively off--; be formed, for example as a clamping device.
  • FIGS. 10 and 11 illustrate details of FIG. 9.
  • the lancet protection element 13 is integrated into the inside of the housing 3, in FIG. 11 it is placed on the inside of the housing 3. Another modification is shown in FIG. 23.
  • FIGS. 12 to 19 illustrate the further sequence after a blood sample has been taken with a lancet 5.
  • the lancet 5 remains in the parking position in the protective element 13 and the lancet drive 8 moves in a separate starting position.
  • the lancet drive 8 remains in the park position together with the lancet 5.
  • the lancet drive with gripper 9 and gripped lancet 5 is first moved downwards.
  • the gripper 9 is rotated under the protective element 13 by means of a rotary movement that takes place in a rotary plane that is as close as possible to the rotary plane in which the pivoting movement takes place to bring a lancet 5 out of the lancet storage container 13.
  • the lancet 5 is brought into the park position by an upward movement, wherein it is pressed into the soft plastic in the protective element 13. There, they can not by a 'shown, active or passive holder are held, the holding force provided by the elastic material 15 is not sufficient.
  • the lancet 5 can preferably be moved by means of the lancet drive 8 into the parking position in which its tip is located in the protective element 13. If a higher design effort can be accepted, a separate drive can also be provided for this, which does not fulfill the function of fetching the lancets 5 from the lancet storage container 6.
  • the design effort and the travel paths of the lancet 5 are minimized if the lancet tip protection element 13 is arranged in such a way that the lancet tip can be inserted into the lancet tip protection element by a movement parallel to the piercing movement.
  • the lancet 5 can be brought out of the park position by means of the lancet drive 8 to carry out a further blood withdrawal. Parking the lancet 5 outside the lancet storage container 6 prevents the lancet storage container 6 or the unused lancets contained therein from being contaminated by sample material adhering to the lancet 5 used. Furthermore, the lancet can be transported from the parking position to the outlet opening for a new one The lancing process takes place more quickly since the lancet storage container 6 does not have to be repositioned in order to remove a new lancet therefrom.
  • the lancet drive 8 first moves upward from the starting position, then pivots the gripper 9 under the lancet 5 in the park position and moves upward somewhat to grip the lancet 5.
  • the lancet drive 8 moves somewhat downward, the lancet 5 being pulled out of the protective element 13, swivels to the left and brings the lancet 5 into the lancing position at the outlet opening 4 by an upward movement, in order to place it in the fingertip 12 sting.
  • the lancet 5 is then no longer required because, for example, the number of lancing operations to be performed with a lancet 5 determined by the user has been reached, the lancet 5 is brought into the lancet storage container 6 for disposal. These steps are carried out in accordance with FIGS. 6 and 7.
  • An advantage of the method according to the invention is that it can include a method step in which a lancet 5, with which a puncturing movement has been carried out, is returned to the lancet storage container 6. It is particularly advantageous that the invention enables the used lancets 5 to be re-stored without soiling the lancet storage container 6 by first moving the used lancet 5 into the parking position after the lancing process, before it is re-stored in the lancet storage container 6.
  • the used lancet 5 is inserted into a lancet tip protection element 13 in the park position before being returned to the lancet storage container 6, that is to say that a used lancet 5 is also first transferred to the park position when it is not intended for any further lancing process.
  • the lancet storage container 6 can be replaced at a suitable point in time, if necessary with used lancets 5 that have been re-stored.
  • the lancet storage container 6 thus only serves to transport the lancets 5 into the blood collection system 1 or the blood analysis device 2, to keep unused lancets in them and to dispose of the used lancets.
  • FIGS. 17 to 19 illustrate the alternative variant, in which the lancet drive 8 remains in the park position after the lancet 5 has drawn blood.
  • 17 illustrates how the lancet 5 is brought into the park position; the process corresponds to the process shown in FIG. 12.
  • the lancet drive 8 is not moved away or pivoted away from the lancet 5 in the park position, but rather the gripper 9 remains in or in the immediate vicinity of the lancet 5 in the park position.
  • Fig. 18 Compared to the end position shown in FIG. 14, this has the advantage that even shorter travel times result for subsequent blood collection with the parked lancet 5, since the travel routes shown in FIG. 15 are omitted.
  • the ones illustrated in FIG. 19 are for performing a further blood withdrawal Perform steps corresponding to those of FIG. 16.
  • a lancet 5 that is no longer to be used is disposed of as in the first variant described above.
  • FIGS. 20 to 22 illustrate a modified embodiment of a blood analysis device 2 with a blood collection system according to the invention.
  • a test element magazine 17 On the top of the blood analyzer 2 there is a test element magazine 17 with a revolver-like removal device 18.
  • the lancets 5 are pushed from bottom to top through the lancet storage container 6 by a lancet drive, not shown.
  • the lancet tip protection element 13 is arranged, which is filled with a gel-like, soft plastic.
  • the parking position defined by the position of the protective element 13 could also occupy a position in the lancet storage container 6.
  • a holding device 19 is arranged under the protective element 13 as a parking aid for the lancets in the parking position, for example in the form of a holding clip.
  • the process flow is illustrated in FIG. 21 in three steps.
  • the lancet drive penetrates from below into a storage position of a lancet 5 in the lancet storage container 6, for example a sealing film ensuring sterility up to this point being pierced.
  • With a removal device tung is gripped a lancet and upwards out of the lance storage container 6, in turn, for example by a sealing film, moved out '.
  • the lancet drive moves the lancet back into the lancet storage container 6, where it is separated from the lancet drive and disposed of according to the prior art.
  • the lancet storage container 6 would rotate one position further for the next blood withdrawal and a new lancet would be used.
  • the used lancet 5 is pulled down through the lancet storage container 6, swiveled to the side by means of the lancet drive, and pushed up into the lancet tip protection element 13 (FIG. 21 right), where it is used for a further use is available.
  • the lancet is transported in reverse order, i.e. first pulled down, then pivoted to the side and conveyed upward through the lancet storage container 6.
  • FIG. 23 illustrates a modified embodiment of the protective element 13. It may possibly happen that during the lancing process (to obtain blood) one
  • Capillary (capillary) is hit and an unexpectedly large amount of blood emerges. This could collect on the lancet 5 in the form of a drop 20. This drop 20 would when the lancet 5 was inserted into the surface of the elastic material 15 (of the parking gel) be stripped. From there, the still liquid blood could run down or accumulate in layers and thus subsequently contaminate the part of the lancet 5 that is not immersed in the elastic material 15. This is remedied by a cover 21 of the elastic material 15 with an absorbent material, for example cellulose or the like. This can absorb the possible drop of blood 20 and bind it. The requirements for the material of the cover 21 are sufficient strength, a high fabric density (suction power and stability for several punctures) and "lint-free".

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Hematology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Geometry (AREA)
  • Manufacturing & Machinery (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne un système de prélèvement sanguin destiné à l'analyse ou au diagnostic. L'invention vise à permettre plusieurs utilisations des lancettes (5) stockées dans un récipient de stockage de lancettes (6), et à réduire le temps s'écoulant jusqu'à l'exécution du mouvement de piqûre. A cet effet, les lancettes (5) sont pourvues d'un élément de protection de pointe de lancette (13) en position de stockage, ledit élément de protection protégeant la pointe des lancettes de façon mécanique et hygiénique.
EP04729840A 2003-06-13 2004-04-28 Systeme de prelevement sanguin Withdrawn EP1631193A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10326692A DE10326692B3 (de) 2003-06-13 2003-06-13 Blutentnahmesystem, Blutanalysegerät und Verfahren zum Entnehmen von Blut
PCT/EP2004/004467 WO2004110274A1 (fr) 2003-06-13 2004-04-28 Systeme de prelevement sanguin

Publications (1)

Publication Number Publication Date
EP1631193A1 true EP1631193A1 (fr) 2006-03-08

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EP04729840A Withdrawn EP1631193A1 (fr) 2003-06-13 2004-04-28 Systeme de prelevement sanguin

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US (1) US20060282109A1 (fr)
EP (1) EP1631193A1 (fr)
JP (1) JP2006527033A (fr)
CA (1) CA2528633A1 (fr)
DE (1) DE10326692B3 (fr)
WO (1) WO2004110274A1 (fr)

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Also Published As

Publication number Publication date
WO2004110274A1 (fr) 2004-12-23
CA2528633A1 (fr) 2004-12-23
US20060282109A1 (en) 2006-12-14
DE10326692B3 (de) 2005-02-17
JP2006527033A (ja) 2006-11-30
WO2004110274A8 (fr) 2006-01-12

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